美国仿制药申报最新要求和案例分析

b****8 · 发表于 2013-2-28 12:38

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本帖最后由 beifan0668 于 2013-2-28 12:44 编辑

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目  录
第一篇美国FDA仿制药评审系统·.......................................................................................... (1)
  第一章FDA仿制药审批简介············································································· (2)
第一节仿制药的审批机构和审批过程·............................................................................ ( 2 )
第二节问卷式评审一一-FDA仿制药最新评审模式·....................................................... ( 4 )
第三节问卷式评审中有关原料药的问题·........................................................................ ( 5 )
第四节问卷式评审中有关制剂的问题·............................................................................ ( g )
  第二章质量源于设计—FDA药物研发的新理念·......................................................... (12 )
第一节原理简介·.............................................................................................................. (12 )
第二节案例分析·.............................................................................................................. (15 )
  第三章通用技术文件—FDA仿制药申请格式·............................................................. ( 23 )
第一节仿制药申请格式简介·.......................................................................................... ( 23 )
第二节通用技术文件结构·.............................................................................................. (24)
第三节首页函和地区行政管理信息·.............................................................................. ( 27 )
第四节通用技术文件总目录·..................................·· .· .................................................... ( 29 )
  附录1-1通用技术文件各单元目录说明······································································……(36)
  附录1-2仿制药申请完整性和可接受性核对清单(C下D或eCTD格式)·············……(43)
  附录1-3  FDA 356h表格·············································································...···············……(53)
参考资料·························································································································……(54)
第二篇质量综合概要(QOS)撰写案例分析·································································(55)
  第一章一般性信息·········································································································……(56)
  第二章QOS原料药部分··························································································……(58)
第一节原料药的制造和鉴定·.......................................................................................... ( 58 )
第二节原料药的控制，...................................................................................................... (61)
  第三章QOS制剂部分···································································································……(73)
第一节制剂的组成和配方·.............................................................................................. ( 73 )
第二节制剂的生产·.......................................................................................................... (85 )
第三节制剂的控制·....................................................................................................... ( 108 )
参考资料·············································································································(136)
第三篇药物管理档案(DMF)撰写案例分析·................................................................... (137 )
  第一章药物管理档案·........................................................................................................ (138 )
第一节药物管理档案简介·............................................................................................ (138 )

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美国仿制药申报最新要求和案例分析

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